BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 3083035 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02654
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIN
    PMA / PMN Number
    P110001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BALANCE MIDDLEWEIGHT. GUIDE CATH: RDC 7 FR. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THE HERCULINK ELITE WAS USED TO TREAT A RESTENOSED STENT. IT SHOULD BE NOTED THE RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU) STATES: THE RX HERCULINK ELITE RENAL STENT SYSTEM IS INDICATED FOR USE IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE RENAL ARTERIES FOLLOWING SUB-OPTIMAL PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) OF A DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESION. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING AN UNSPECIFIED REVASCULARIZATION PROCEDURE OF THE PROXIMAL RENAL ARTERY, THE HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS DELIVERED TO THE LESION BUT DURING REPOSITION THE STENT DISLODGED FROM THE BALLOON AND REMAINED ON THE GUIDE WIRE. THE SDS WAS REMOVED AND A 1.5 X 8 MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS POSITIONED INSIDE THE DISLODGED STENT AND PRESSURIZED TO 8 ATMOSPHERE (ATM). THE STENT WAS POSITIONED AT THE LESION AND APPOSED TO THE VESSEL WALL USING THE MINI TREK. ADDITIONALLY, A 3.0 UNSPECIFIED BDC AND A 5.0 X 20 MM UNSPECIFIED BDC WERE USED TO FULLY APPOSE THE STENT IN THE TARGET LESION AND POST DILATED FOR A GOOD RESULT. IT WAS NOTED THAT A SLIGHT RESISTANCE WAS FELT WHEN THE STENT WAS BEING REPOSITIONED AND THE PHYSICIAN IN HINDSIGHT FEELS THE HERCULINK ELITE MAY HAVE CAUGHT ON THE STENOSED RENAL STENT. THERE WAS NO REPORTED DAMAGE TO THE FIRST STENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185244 RX HERCULINK ELITE STENT SYSTEM STENT SYSTEM NIN AV-TEMECULA-CT 2121761

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention